Phase 2
N=31
Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
Low-Grade Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00003499 ↗Enrolled (actual)
31
Serious AEs
32.3%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Objective Response — 1; 2; 14; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antineoplaston therapy (Atengenal + Astugenal) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Burzynski Research Institute
- Primary completion
- Sep 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
1; 2; 14; 6 | — |
| SECONDARY Percentage of Participants Who Survived |
29; 28; 21; 17; 14; 11 | — |
Summary
Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC greater than 2,000/mm^3
- Platelet count greater than 20,000/mm^3
Hepatic:
- Bilirubin normal
Renal:
- Creatinine normal
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious active infections
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since immunotherapy and recovered
- No concurrent immunomodulating agents (e.g., interferon, interleukin-2)
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- At least 4 weeks since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents
- No concurrent antibiotics, antifungals, or antivirals
Data sourced from ClinicalTrials.gov (NCT00003499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.